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临床试验/CTRI/2015/09/006171
CTRI/2015/09/006171尚未招募2 期

11 beta HSD-1 gene polymorphism in patients with type 2 diabetes, metabolic syndrome and PCOS- Effect of carbenoxolone (Licorice) on anthropometric and metabolic parameters of patients with this polymorphism

RSSDI1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年9月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
RSSDI
入组人数
40
试验地点
1
主要终点
1.Change from baseline FBS, PPBS and fructosamine.

研究概览

简要总结

Diabetes has become one of the major causes of morbidity with more than 285 millions worldwide having this condition. The prediabetic conditions like metabolic syndrome (metS) and polycystic ovary syndrome (PCOS) are also increasing in prevalance. Type 2 diabetes, metS and PCOS show charcteristic insulin resistance in subjects, which is why they are closely related. Subjects with these conditions are characterised by cushingoid features. 11 beta HSD enzyme which has a major role in glucocorticoid (GC) metabolism may alter GC action due to the polymorphism in the gene encoding them. Recently much attention has been given to the pharmacological manipulation of cortisol metabolism as therapeutic strategy. 11 B HSD-1 inhibitor like licorice is known to decrease local GC generation, decrease blood glucose, lipids and improve insulin sensitivity. Licorice is been used in medicine for more than 4000 years. It is used as anti-ulcer,anti-inflammatory agent, demulcent, expectorant, laxative, sweetener, bronchodilator,diuretic,anti-pyretic,rejuvenator, skin fairness,etc. Our current study is to explore the role of 11 B HSD-1 gene polymorphisms in subjects with type 2 diabetes, metS and PCOS and to study the pharmacological use of licorice (carbenoxolone) in treatment of these abnormalities by their interference in cortisol metabolism.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patients who sign informed consent Type 2 diabetics confirmed by ADA criteria Metabolic syndrome subjects confirmed by IDF criteria Polycystic ovary syndrome subjects confirmed by rotterdam criteria.

排除标准

  • Type 1 diabetes Diabetics on insulin Subjects with HbA1C>9.5%, FBS>200 mg/dl, BP>160/100,eGFR>30% Known hypokalemia Oedema Women of child bearing potential Currently on alcohol abuse.

结局指标

主要结局

1.Change from baseline FBS, PPBS and fructosamine.

时间窗: 3 weeks

2.Proportion of patients who maintain good short term glycemic control without the need of additional antidiabetic medication.

时间窗: 3 weeks

3.Change from baseline weight, waist circumference 4.Change from baseline in total cholesterol, LDL, HDL, triglyceride

时间窗: 3 weeks

次要结局

  • Proportion of patients who show hypokalemia, oedema, elevation of blood pressure of 5 mmHg or more and other side effects(Baseline and every week upto 3 weeks)

研究者

发起方
RSSDI
申办方类型
Government funding agency

研究点 (1)

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